Your Challenges
The life science industry continues to struggle with challenges such as rising costs, securing innovation throughout the product life cycle, and implementing the right digital solutions:
- Unsustainable healthcare costs and chronic disease prevalence are driving payer controls and reform based on value and outcomes; however, providing true outcomes-based care delivery remains a challenge
- The digital explosion continues to fuel the hope for unprecedented insights about individuals and health – as well as decentralizing clinical development
- Empowered patients and consumers want more effective therapies and value in convenient settings
- Tougher regulations increase emphasis on risk management and surveillance
- The pandemic has shown that regulators across the globe can approve drugs faster, putting more pressure on them to perform
- Increase in failure of innovative therapies and other ideas, some in later stages; much of this is due to high amount of capital in markets, but signs are this is declining
- The pressure to increase diversity in clinical trials is mounting
Companies are becoming more agile in how they secure their competitive position and profitability
- Companies have become more agile, reacting quickly to business disruption, but quality and operational discipline is lagging
- New business models are being developed, e.g. focused on diagnostics, data or technology as sources of revenue, while having to more quickly integrate these into existing operations
- Real-World-Evidence (RWD) is being embedded with some success into R&D, and other players (e.g. pharmacies) are trying to enter the market
- Regulators were able to react quickly during the pandemic, however it is questionable if this trend will continue
Investment in digital solutions continues, but at a slower pace and more conservatively - Companies are taking advantage of learning from the pandemic e.g. risk-based monitoring and virtual site visits, but embedding them at scale is challenging
- There is an increase in divestment of non-core businesses, while cooperations, particularly in R&D, are increasing (e.g. small / large pharma, academic medical centers)
However, additional changes are required
- Ability to change R&D operating models quickly to gain efficiencies based on new trends
- Relentless (professional) project management to effectively manage both change programs and development projects
- Rigorous, ongoing evaluation of assets to make faster go/no-go decisions earlier
- Faster, more effective start-up of clinical study sites
- Faster assessment of new technologies for viability, whether embedded in products or driving operational improvements
- Ability to quickly enter new markets and develop global growth strategies, regardless of size of company
Caniu – your competent partner in life sciences industry
Our experienced industry veterans and consultants are ready to help you address your challenges or develop innovative solutions through our
- Experienced team of consultants,
Whether it be as management consultant or executive in mid-size companies
- Proven, highly qualified network partners (associate partners)
To successfully address industry or function-specific challenges
- Comprehensive methods
to successfully plan and implement change – cost effectively and quickly – together with your team members
Additional network partners with expertise in
- R&D, such as scientists, MDs, regulatory experts, etc.
- Tax and accounting
- Private equity with access to public financial institutions
- Corporate, labor and patent law
- Corporate finance
Please contact us We would welcome the opportunity to outline our customized approach for your specific situation or needs..
Within the life science industry, we focus on biotech startups, mid-size biopharma, and large pharma.
Expansion into new markets - a strategic opportunity
Caniu's Expansion goal is to quickly and efficiently expand into new markets. We provide value through our experienced team of consultants and industry experts, a proven approach to goal-oriented market expansion strategies, and a network of industry specialists.
Your challenges – our starting point for expansion
• Is there potential to increase revenue in new markets?
• Does expansion into new markets require a development partner or an investor?
• Is the initial establishment of a local affiliate with a small team required? Is this team expected to grow as revenue grows?
• Does a budget for the international expansion need to be developed, inclusive of costs, milestones, resources, and impact on any development activities?
We apply our wealth of experience to help you expand into new markets – quickly and efficiently.
Our Approach
- Proven approach to strategic planning through efficient and thorough consideration of product portfolio, development activities, market potential and payer strategies in addition to medical, scientific and operational requirements in target markets
- Efficient and comprehensive development of a basis for decision-making by including relevant experts with knowledge of the target markets and through active support from all team members (internal and external)
- Goal-oriented faciliation of discussions with potential development partners or other investors in the target markets
- Flexible and professional project management and operational support to ensure timely completion of all activitie
Our Proven Services
- Expansion strategy
- Outcomes and benefits – realistic market expansion implementation plan (e.g. for North America or Europe) and identification of potential development or commercialization partners as well as investors supported by our team of highly qualified experts (e.g. R&D, Regulatory, commercialization) as well as management consultants
- Interim Management
- Outcomes and benefits - faster or secured revenue growth through the use of industry leaders with relevant international R&D or commercialization experience O
- Operational support
- Outcomes and benefits – operational affiliates and reliable local business partners and/or secured third-party investment through operational support of the implementation of the expansion strategy (e.g. establishing local affiliate or management teams) or partner or investor negotiationstrategieerstellung
Caniu - Your competent partner for a better business expansion
Our experienced management consultants, business coaches and interim managers are ready to help you expand into new markets. Our contribution includes
- An experienced team of consultants
- whether as heads of portfolio or project management, executive team member or management consultant for start-ups, mid-tier and large life science organizations
- Highly qualified network partners (associate partners) with in-depth global functional experience
- Comprehensive methodology and templates to successfully plan, implement, and facilitate and work effectively with your team members
- Network of highly qualified experts with specific functional expertise
- Scientists
- MDs
- Regulatory experts
- Commercialization or payer experts, etc.
Please contact us if you would like to learn more about our business expansion services. We would welcome the opportunity to outline our customized approach for your specific situation or needs..
Our expansion services are specifically designed for life science startups and midsize biotechs
Asset Evaluation – reduced costs and increased value of R&D
Caniu's Asset Evaluation goal is to reduce cost and/or time to market through enabling faster Go / No Go decisions or improve the potential value of your developmental therapies. We provide value through our experienced team of consultants and industry experts, a proven approach to efficient and effective product risk identification and optimization or design of development strategies and a network of industry specialists.
Your challenges – our starting points for asset evaluation
- Are you unsure how to progress your asset when considering the competitive landscape, approval risks, medical success, and market potential?
- Are decision-makers not able to come to a consensus?
- Would you like to out-license or in-license an asset but don't have the appropriate expertise or capacity? Are you looking to acquire or merge with another company? Do you need more in-depth experience to support your due diligence activities?
- Do you have a Go / No Go decision framework for individual assets (as well as on portfolio level) that allows decisions to be made quickly and effectively and can be supported by all?
- We apply our wealth of experience in evaluating assets to help you make faster, well-informed Go / No Go decisions, irrespective of phase of development.
Our approach to effectively and efficiently evaluating your assets
- A practical and experience-based review and analysis of all relevant data, including Target Product Profile (TPP), development plan (costs and budget, timelines, resource needs, risks), market potential and payer strategy in addition to medical, scientific, operational and regulatory components
- Efficient development of a specific asset-based decision framework using relevant experts in cooperation with your team members (internal and external)
- Target-oriented decision-making process that includes all stakeholders
- Integration of a more efficient decision-making process in your organization to help make future decisions more effectively
Our proven services
- Asset Evaluation
- Outcomes and benefits – Faster Go / No Go decision-making, cost reduction, value increase, or reduction of time-to-market through a comprehensive asset assessment based on medical, scientific, commercial, payer, development or regulatory factors
- Process Implementation
-
- Outcomes and benefits – Significant cost reduction through a faster, more effective decision-making process
-
Caniu – Your competent partner for a better asset evaluation
Our experienced management consultants, business coaches and interim managers are ready to help optimize your assets. Our contribution includes
- An experienced team of consultants whether as heads of portfolio or project management, executive team member or management consultant for start-ups, mid-tier and large life science organizations
- Highly qualified network partners (associate partners) with detailed functional experience
- Comprehensive methodology and templates to successfully plan, implement, and facilitate and work effectively with your team members
- Network of highly qualified experts with specific functional expertise and experience working in life science development teams as
- Scientists
- MDs
- Regulatory experts
- Commercialization or payer experts, etc.
Please contact us if you would like to learn more about our asset evaluation services. We would welcome the opportunity to outline our customized approach for your specific situation or needs.
Our asset evaluation services are specifically designed for life science startups, midsize biotechs or large biopharma.
Project Management and Turnaround – sustained success of your critical development projects
Caniu's Project Management and Turnaround goal is to optimize your development projects by improving budget utilization
Your challenges – our starting point for project management and turnaround
- Do you have a development plan that is realistic and convincing up to the next decision milestone? Is it "on track" and task and outcome oriented?
- Does this plan allow effective Go / No-Go decisions to be made on portfolio or executive team level in order to save costs or increase product value?
- Are you struggling to meet timelines and stay within budget? Is there clear communication on timeline and budget expectations?
- Does your development team work as a cohesive unit and interact effectively with senior management or other decision-making bodies?
We apply our wealth of experience in leading, managing and rescuing development projects to help you develop realistic project plans, successfully manage and lead them, or rescue struggling projects, regardless of phase of development.
Our approach to effective project management and turnaround
- A practical and success-oriented development plan with proven elements (e.g. TPP (Target Product Profile), Costs, Timeline, resource needs, risks) embedded in an effective decision-making framework
- Goal-oriented, professional and adaptive project leadership and management with active support from all team members (internal and external) that effectively interacts with all decision-making bodies (R&D governance, functional leadership)
- Ongoing risk and compliance management aligned with strategic corporate goals
- Rapid current state analysis combined with realistic turnaround recommendations, taking into account corporate goals, skills, alignment within the matrix organization and supporting (IT) tools
Our proven services
Health Check und Quick-Wins
Outcomes and benefits - a "ready-to-implement plan" that will improve performance of individual projects or the entire project management function based on an analysis of skills, processes and (IT) tools and individual project metrics (costs/budget, resources, timelines) and comparison to industry practices; initiation of quick wins
Interim Project Management
Outcomes and benefits – Improvement of project performance (cost, resources, timelines) and timely decision-making through the use of experiences leaders and managers that effective facilitate and coach existing project teams
Project Management Implementation
Outcomes and benefits – Improved project performance (costs, resource utilization, timelines),faster decision-making and motivated team members through implementation of a new project management capability (structure, skills, processes and IT tools) and decision-making frameworks driven by a measurable business case
Project Rescue
Outcomes and benefits – Rapid improvement of project performance for projects with significant delays or budget overruns through a systematic root cause analysis (Health Check) and deployment of appropriate (interim) project leaders or managers
Caniu – Your competent partner for better project management and turnaround
Our experienced management consultants, business coaches, or interim managers are ready to support your development project needs. Our contribution includes
- An experienced team of consultants whether as heads of portfolio or project management, executive team member or management consultant for start-ups, mid-tier and large life science organizations
- Highly qualified network partners (associate partners) with detailed functional experience
- Comprehensive methodology and templates to successfully plan, implement, manage risk and work effectively with your team members
- Network of highly qualified experts with specific functional expertise and experience working in life science development teams as
- Scientists
- MDs
- Regulatory experts
Please contact us if you would like to learn more about our development project management and turnaround services. We would welcome the opportunity to outline our customized approach for your specific situation or needs.
Our project management and turnaround services are specifically designed for life science startups, midsize biotechs or large biopharma.
R&D Optimization – from customized optimization to complete realignmentCaniu
Caniu's R&D optimization goal is to improve the R&D operating model through enhanced organization structures, skills, processes, and/or IT systems. We provide value through our experienced team of consultants and industry experts, a proven approach to developing R&D operating models, and a network of industry specialists
Your challenges – our starting point for R&D optimization
- Is your current R&D organization innovative and efficient based on its ability to get new products to market within budget and before the competition?
- Does your R&D function adapt flexibly to new trends or business disruptions such as Real-World-Evidence (RWE), Risk-Based-Monitoring (RBM), and pandemics and can it make appropriate process and organizational changes quicklly?
- Are your supplier (e.g. CRO) costs appropriate und are their services provided efficiently and without much oversight?
- Are you exploring new revenue sources, such as ompanion Diagnostics oder data and analytics services?
We apply our wealth of experience to help you optimize R&D – quickly and efficiently.
Our Approach
- Proven approach for R&D design inclusive of all elements such as structure (Organization, resources, processes, IT systems) as well as „innovation efficiency" (costs, innovation potential (pipeline), operational metrics), all aligned with strategic business goals
- Successful implementation through professional project leadership and active change management driven by a transparent and measurable business case
- Goal-oriented, professional and adaptable leadership of R&D functions with active support from all team members (internal and external)
- Ongoing risk and compliance management as well as change management aligned with strategic business goals
- Continuous evaluation of industry trends applied to project objectives, design and implementationit
Our Proven Services
Health Check und Quick-Wins
o Outcomes and benefits - a „ready-to-implement plan" that will improve all of R&D through assessment of the entire structure (organization, resources, processes, IT systems) as well as „innovation efficiency" (costs, innovation potential (pipeline), operational efficiency) compared to industry practices and initiation of quick wins
• Interim Management
o Outcomes and benefits - improved R&D performance (e.g. innovation and operational efficiency) and faster decision-making through the use of experienced leaders and functional managers (e.g. clinical development or operations, therapeutic areas, regulatory affairs, pharmacology)
• R&D Design
o Outcomes and benefits - a „ready-to-implement design" to improve R&D performance that considers organization, resources, processes, and IT systems
• R&D Design Implementation
o Outcomes and benefits - improved R&D performance (e.g. innovation and operational efficiency), faster decision-making and motivated team members through implementation of the new R&D design (organization, resources, processes, IT systems) driven by a measurable business case
Caniu – Your competent partner for improved R&D performance
Our experienced management consultants, business coaches and interim managers are ready to help you optimize your R&D function. Our contribution includes:
• An experienced team of consultants
whether as heads of specific R&D functions, executive team members, or management consultants for start-ups, mid-tier or large life science organizations
• Highly qualified network partners (associate partners)
to help resolve complex business issues
• Comprehensive methodology and templates
to quickly and cost effectively plan, implement, and manage risk together with your team
• Network of highly qualified experts with specific functional skills
o Scientists and MDs
o Regulatory experts
Please contact us. if you would like to learn more about our R&D optimization services. We would welcome the opportunity to outline our customized approach for your specific situation or needs..
Our R&D optimization services are specifically designed for life science startups, midsize biotechs or large biopharma.
